I/C LIQUID PACLITAXEL FOR THE PREVENTION OF RESTENOSIS

Many of us may know that the NHAM is holding the MyLive ( live demo course ) in KL Hilton these few days ( 30th July-1st Aug 2009 ). Looks like there is not much new hard-ware, and it is mainly a meeting of friends with some discussion of techniques and how to avoid complications and how to deal with them should they happen. Of course, part of the reason that PCI has reached a plateau, is because there is not much more to innovate for PCI and the big American boys have become interested in percutaneous heart valve replacement, something we are waiting anxiously for proof of safety. I was MyLive briefly in the evening to chair a session and also to meet up with some old friends. Well, any time like minded interventionist meet together to exchange ideas is always good. The cost is another factor altogether. CME costs does impact on the consumer ultimately.
At night, I was invited to dinner to hear about the latest development in Drug-Eluting Balloon ( DEB ). Personally, I was hoping for some updates on the latest trial results, but I did not get to hear that. It was more a " my experience session ", and in that sense I was a bit disappointed. Of course the commadarie was good. I met many old friends and also make many new friends there. I was trying to see how to position the use of the DEB, in the whole armentarium available to me in the treatment of CAD. For the moment, I was trying out the use of the DEB in the management of select cases of " in-stent restenosis " . I was hoping that a wider review of PEP-CAD II would give me more support. Anyway, that did not come.
In the 22nd July on-line issue of Circulation : Cardiovascular Intervention, Dr C Herdeg and colleagues from Turbingen, published a small clinical trial called LOCAL TAX, on the use of I/C liquid Paclitaxel, in the treatment of CAD. They studied 204 patients with CAD who were divided into 3 groupd, group 1 were trated with bare metal stents + I/C liquid paclitaxel, Group 2 were treated with bare metal stents and Group 3, with the DES Taxus ( which is paclitaxel eluding ). Well, the 6 months late loss, was obviously worse with bare metal stents ( 0.99mm ) and the best with group 3 ( 0.44mm ). The late loss of Group 1 came in-between at 0.61mm ( not inferior to group 3 ). The difference in late loss of Gp1 and 3 did not translate to any significant clinical events. From this small pilot study, it would appear that we can just use I/C liquid paclitaxel. Of course, paclitaxel here is advangtages ( when compare to the limus group becoause paclitaxel is lipophilic and limus are hydrophilic.
Anyway, this trial raises a few issues in my mind. Firstly, look like Germans are very keen of not placing material in patients artery. They like DEB which will be removed and also liquid paclitaxel, which will be at the arterial wall and also washed away. The rest of Europe and the USA seem not so keen. Maybe that will why, it may be very difficult for DEB to get CE mark and US FDA approval. Secondly, looks like a bit of paclitaxel locally in the vessel wall can exert a significant activity and effect. We inflate the DEB for 20-30 secs and we retain the liquid by a perfusion like balloon for the same duration and get the effect. Will we see a day went we can just dip the balloon in a vial of Paclitaxel and then introduce it across the target site, and get positive results. Interesting thought. That will of course be cheaper then DES, DEB and IC liquid paclitaxel.
Well, I am back to chair another session this evening on " cutting edge PCI ". Lets see what they will teach me.